Containers and methods for delivering vaso-occluding filaments and particles

ABSTRACT

Containers for holding and delivering vaso-occluding materials, such as hydrogel particles and filaments include a fluid inlet port and a fluid outlet port that are respectively fluidly connectable with a fluid source and a delivery catheter. The vaso-occlusive materials may be held in the container in a hydrated or unhydrated state. The container further includes at least one chamber or passageway extending therebetween. The passageway may be straight, curved, spiral, helical, narrow or otherwise shaped. The chamber may also have sections of varying cross section such as a ramped section. The shapes of the passageways of the container help organize ejection of the vaso-occluding materials minimizing contamination and clumping.

CROSS REFERENCE

[0001] This application is a continuation-in-part of application Ser.No. 10/106,483 (atty. docket no. 21186-000400US), filed on Mar. 25,2002, the full disclosure of which is incorporated herein by reference.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention.

[0003] The present application is directed generally at medical devicesand methods and, more particularly, containers and methods for holdingand delivering vaso-occluding filaments and particles.

[0004] Numerous persons experience some form of hemorrhagic stroke orblood vessel rupture in the brain. Ruptures can occur with a number ofabnormalities including arterio venous malformations (AVM), aneurysms (aballooning of the arterial wall), fistulas, or a burst blood vessel.Additionally, abnormal vasculature is generated in the process of tumorgrowth requiring larger than normal blood flow to sustain the tumor.

[0005] Endovascular therapies for treating vessel ruptures and bloodflow abnormalities include implanting vaso-occlusive agents, coils andother devices such as that described in U.S. Pat. No. 4,994,069, andinjecting hydrogel vaso-occluding particles and filaments into thevessels to be treated, as described in U.S. Patent ApplicationPublication Nos. 2002/0193813A1; 2003/004533A1; 2003/0004568A1; and2002/0193812A1, each of which are assigned to the assignee of thepresent application and are hereby incorporated by reference in theirentirety.

[0006] Injecting vaso-occluding materials, however, requires carefulhandling in order to avoid various problems. For example, the particlesand filaments may clump and clog the lumens and openings of thedispensing containers and instruments. The small size of the particlesand filaments makes them inconvenient for a doctor to handle. Inparticular, capturing/collecting a filament in a solution is difficultdue to their small size. The vaso-occluding material may be contaminatedduring the mixing or transporting step. The vaso-occluding materials maybecome damaged during shipping and storing. For example, when hydrogelfilaments are shipped in an unhydrated state, they tend to be brittle.Such filaments are particularly vulnerable to breaking during shipping.

[0007] For these reasons, it would be desirable to provide improvedapparatus and methods for delivering vaso-occluding elements,particularly hydratable particles and filaments. The apparatus andmethods should avoid clumping and tangling of the vaso-occludingelements prior to and during delivery and should further avoid cloggingof the delivery apparatus during delivery. In particular, the methodsand apparatus should in at least some instances permit delivery ofindividual vaso-occluding elements singly, i.e. one at a time. Theapparatus and methods should also facilitate and improve the collectionand storage of the vaso-occluding elements prior to use. It would befurther desirable to provide for storage of the vaso-occluding elementsin either a hydrated or non-hydrated condition and, in the latter case,permit convenient hydration in the storage container prior to use. Inall cases, it would be desirable that the stored vaso-occluding elementsbe protected during storage and shipment. At least some of theseobjectives will be met by the invention described hereinafter.

BRIEF SUMMARY OF THE INVENTION

[0008] Described herein are kits, containers and methods for holding anddelivering vaso-occluding elements, including both filaments andparticles. In one variation, the kit comprises a plurality of hydratablevaso-occluding elements and a container holding the hydratablevaso-occluding elements. The container has an inlet port and an outletport. At least one of the fluid inlet and outlet ports is adapted tofluidly connect with a fluid source, typically a pressurized fluidsource such as a syringe. The fluid inlet port may be configured forreceiving liquid to hydrate the vaso-occluding particles and the fluidoutput port may be configured for dispensing the liquid and thevaso-occluding particles, typically into an implanted catheter havingdelivery to a target location in a patient's body.

[0009] The container will usually include at least one chamber orpassageway to hold the particles. The passageway or chamber may havevarious shapes. For example, the passageway may be straight, curved,conical, narrow, spiral, helical and otherwise shaped. The containerand/or chamber(s) and passageway(s) may have multiple sections and thesections may have varying cross sectional areas. The various constructsof the chamber facilitate introduction of the particles into thedelivery catheter.

[0010] The characteristics of the elements may vary. In one variation,the elements are particles having an outer width or diameter in therange of 40 μm to 2 mm, usually 100 μm to 1400 μm. In another variation,the elements are filaments, typically having a length in the range from0.5 mm to 1000 mm, usually from 10 mm to 1000 mm, and often from 10 mmto 100 mm, and a width or diameter in the range from 75 μm to 5 mm,usually from 100 μm to 2 mm, and often from 100 μm to 1 mm. The elementswill be hydratable, i.e. capable of absorbing saline or other aqueousmedium (referred to hereinafter as a hydration or hydrating medium),typically being formed from a polymeric hydrogel material, moretypically being formed from a natural or synthetic polymer. Aparticularly preferred polymer is polyacrylonitrile, but a variety ofother suitable polymers are listed hereinbelow.

[0011] In another variation, the elements are particles and thecontainer includes a mixing member. The mixing member may be elongateand have a first section outside of the container and a second sectionwith, for example, a stirrer that contacts and moves the particles whenthe stirrer is rotated.

[0012] Another container includes a conical distal end section. Theconical distal end section decreases in diameter towards the fluidoutlet port. The conical portion may be sized to fit within the proximalend of a delivery catheter.

[0013] Another container includes at least one fluid relief port and atleast one fluid relief passageway fluidly connected with the fluidrelief port. The fluid relief port may have a size smaller than that ofthe particles such that the particles cannot pass therethrough. Thefluid relief passageways may extend to the fluid outlet port such thatliquid driven through the container flows through the chamber and thefluid relief passageway while the particles are permitted only to flowthrough the chamber.

[0014] In another variation, the container may include at least oneone-way valve.

[0015] In another variation, the container includes a membrane orscreen. For example, the container may comprise a first chamber in fluidcommunication with an inlet port and a second chamber in fluidcommunication with an outlet port. The first chamber and the secondchamber may be separated by a support member having at least one openinglarger than the vaso-occluding particles or filaments. When the openingis not covered, fluid and the occluding materials may pass through. Thecontainer may further comprise a movable screen positioned across thesupport and the screen may include at least one particle-blockingsection and at least one particle-passing section. The particle-blockingsection has a plurality of apertures smaller than the particles and theparticle-passing section has at least one aperture larger than theparticles. The screen is movable such that when the particle-passingsection of the movable screen is aligned with the opening of the supportthe particles may enter the second chamber. Also, when theparticle-passing section of the movable screen member is not alignedwith the opening of the support the particles may not enter the secondchamber.

[0016] In another variation, the container may include a fluid outletand a screen member disposed across the outlet. The screen member may befixed and the outlet may be coverable. The screen member may have aplurality of apertures and each of the apertures is smaller than theparticles or filaments such that the particles may not pass through theoutlet.

[0017] A kit may also include a cap to cover one or both of the fluidinlet and fluid outlet ports. Additionally, the fluid inlet and fluidoutlet ports may have Luer-type or other threaded fitting to fluidlyconnect the syringe and delivery catheter to the container.

[0018] Another kit comprises a hydratable filamentary occluding materialand a container holding the material. The material may comprisepolyacrylonitrile. The container may have a first opening for fluid flowand a second opening for fluid flow and exit of the filamentaryoccluding material. At least one of the openings may be adapted forconnection to a fluid source such as a syringe.

[0019] Also, one of the first and second openings may be adapted forconnection with a delivery catheter. The container may further includeat least one chamber or passageway to hold the fluid and the filaments.

[0020] The passageway or chamber may be variously shaped. For example,the passageway may be straight, curved, conical, narrow, spiral, helicaland otherwise shaped. The container may have multiple sections and thesections may have varying cross sectional areas. The various constructsof the chamber facilitate introduction of the particles into a deliverycatheter.

[0021] In another variation, the passageway of the container isconfigured to allow only one filament of occluding material passtherethrough at a time. The diameter of the passageway may be in therange of 100 μm to 5 mm.

[0022] Also, the shape of the container itself may vary. The containermay have, for example, a disk-, card-, cylindrical-, or turnip-shape.The container may also include a screen or membrane. The membrane mayhave openings sized to prevent the filament material from passingtherethrough but allow liquid to pass therethrough.

[0023] Another container includes a rotatable barrel. The barrel mayhave multiple passageways for holding filaments and a body having asingle ejection channel. To deliver a selected filament, one of themultiple passageways is aligned with the channel such that a fluidpathway is formed from the fluid source to the outlet port of thecontainer.

[0024] A method for holding and introducing vaso-occluding materialsinto a delivery catheter is also provided herein. The method may includethe steps of hydrating the material in a container and pushing at leasta portion of the material from the container, to a target site. Thepushing step may be performed using fluid pressure or a displacingmember. The occluding materials may be a filament.

[0025] The method may also include the additional step of severing thefilament at a selected location along the length of the filament. Thesevering may be performed e.g., by pinching, cutting, ablating,twisting, pulling, or similarly detaching the filament. The pinching maybe performed using an expandable balloon. Also, the breaking may beperformed using a noose or snare. The point of severing may be distal orproximal to the distal end of the catheter and perhaps, within thecontainer.

[0026] Yet another method includes an additional step of detectingdiscrete sections of the filament along its length. The sections may bemarked or enlarged to provide information or feedback to a doctor orphysician. The filament may then be broken at a selected point upondetecting a certain number of segments. The point of severing may bedistal or proximal to the distal end of the catheter and perhaps, withinthe container.

[0027] A preferred container for holding hydratable vaso-occludingelements comprises a delivery tube having an inlet end, a delivery end,and a lumen extending from the inlet end to the delivery end. Thedelivery tube has a length of at least 5 cm, typically being from 10 cmto 10 m, usually from 20 cm to 1 m, and often from 100 cm to 500 cm, andthe lumen has a maximum width along the length in the range from 75 μmto 5 mm, typically from 250 μm to 2 mm. The lumen of the delivery tubeprovides the passageway or chamber for holding the hydratable elements,and its narrow, elongated configuration is particularly useful since itpermits the controlled delivery and dispensing of the elements. Inparticular, the length and width of the lumen may be selected to receivesingle filaments in a manner where the filaments do not fold onthemselves or otherwise become clogged or restricted within the lumen.Similarly, the luminal dimensions can be selected to permit arrangementand dispensing of particles in a single file, i.e. where the width ofthe lumen is equal or greater than the particle width but limited topermit passage of only a single element at a time, e.g., being less thantwice the particle width, so that particles may not pass each other inthe lumen.

[0028] The delivery tube will further include an inlet coupling disposedon the inlet end, where the inlet coupling is adapted to be fluidlycoupled to a syringe or other fluid source, typically being a Luerfitting. As the delivery tube is typically lengthy, it will usually beconfigured to reduce its length, typically having at least a portionconfigured as a helix, spiral, serpentine structure, or other folded ormeandering path which will reduce the container length while maintainingthe length of the delivery tube lumen. Depending on the pattern in whichthe delivery tube is configured, the delivery tube may be mounted onvarious substrates or matrices. For example, helical delivery tubes maybe wound over a cylindrical barrel, be wound inside of a cylindricalbarrel, or the like. Spiral and serpentine delivery tubes may be mountedon planar cards. The containers and the hydratable elements may besupplied to the user separately, but will more usually be supplied incombination. For example, the hydratable vaso-occluding elements may bestored or maintained within the delivery tube lumen in a hydrated state,a partially hydrated state, or a non-hydrated state. In all cases, boththe container and the hydratable elements will be sterile and maintainedin a sterile package, such as a pouch, tube, box, blister card, or thelike. Alternatively, the container and the vaso-occluding elements maybe packaged in separate sterile containers, where the vaso-occludingelements again may be maintained in a hydrated, partially hydrated, ornon-hydrated state. In all cases, when the vaso-occluding elements areprovided in a non-hydrated or partially-hydrated state, it will benecessary to combine and mix the particles with a suitable hydratingmedium, which medium may also be provided as part of the kit or system.

[0029] In preferred constructions, the delivery tube of the containerwill have a generally straight end formed over a length of at least 1cm, where the straight end is adapted to be received in a hub of adelivery catheter, such as a micro catheter having a hub passage with adiameter in the range from 0.4 mm to 5 mm, typically from 0.5 mm to 1.5mm. Usually, the hub passage which receives the end of the delivery tubewill be tapered. In some instances, the straight delivery end of thedelivery tube will also be tapered in order to mate with and form a sealwith the tapered passage of the hub. Alternatively, a spherical or otherseal may be provided over the straight end of the delivery tube in orderto provide a seal with the passage in the hub of the delivery catheter.

[0030] In another preferred aspect of the present invention, a methodfor introducing vaso-occluding elements into an implanted cathetercomprises providing said elements in a hydration liquid in a deliverytube having the dimensions set forth above. The delivery end of thedelivery tube is mated with the hub of an implanted catheter, and theelements in the hydration liquid are transferred from the lumen andthrough the delivery end of the delivery tube into a lumen of theimplanted catheter. The elements may thus be delivered to any targetsite in the body to which the implanted catheter is directed. Themethods of the present invention may employ delivery tubes configured inany of the geometries described above in connection with the apparatusof the present invention.

[0031] In preferred aspects of the method, providing may comprisedrawing said elements from a pool of hydrated elements into the lumen ofthe delivery tube. For example, when the elements comprise filament(s),drawing may comprise applying a vacuum on an inlet end of the deliverytube to capture an end of the filament and draw the length of thefilament into the lumen of the delivery tube. Usually, the lumen willhave been primed with the hydration liquid using a syringe, where thesyringe is the used to apply the vacuum to capture the filament.Alternatively, the delivery tube may be provided as a sterile packagewith the elements in the lumen, either in a hydrated, partiallyhydrated, or non-hydrated form.

[0032] Mating of the delivery end of the delivery tube with the hubpassage usually comprises forming a seal between the delivery end of thedelivery tube and the passage of the catheter hub. The seal may beformed by engaging a tapered region of the delivery end in a taperedpassage of the catheter hub. Alternatively, sealing may be performed bymating a spherical seal, plug element typically on the delivery end ofthe delivery tube in a tapered passage of the catheter hub. Stillfurther alternatively, mating may comprise forming a hemostatic sealover an exterior of the distal end of the delivery tube, where the sealextends to the passage of the catheter hub.

[0033] After the delivery end of the delivery tube has been mated andsealed with the catheter hub, the vaso-occluding elements aretransferred to a catheter lumen, typically by applying pressure at aninlet end of the delivery tube lumen. Pressure causes the fluid andvaso-occluding elements to flow into the lumen of the delivery catheter.Alternatively, transfer may be achieved by passing a pushrod through aninlet end of the delivery tube lumen and pushing the elements with therod. The latter approach provides for precise transfer of thevaso-occluding elements, particularly for filaments where the lengthdelivered from the delivery end of the catheter may be carefullymonitored and controlled.

[0034] In yet another aspect of the present invention, a system fordelivering vaso-occluding elements comprises at least one hydratablevaso-occluding element having a width when hydrated. A delivery tubehaving an inlet end, a delivery end, and a lumen extending from theinlet end to the delivery end is adapted to hold the hydratablevaso-occluding element(s). In order to avoid tangling of individualfilaments and to assure single-file delivery of multiple particles andfilaments, the lumen of the delivery tube has a width along its lengthwhich is at least as large as the width of the vaso-occluding elementand typically (although not necessarily) less than twice the width ofthe vaso-occluding element.

[0035] In yet another aspect, methods according to the present inventionfor delivering hydratable vaso-occluding elements to a target bodylocation comprise singly dispensing one or more vaso-occluding elementsthrough a delivery tube to a catheter lumen. The lumen of the deliverytube is adapted to pass only a single vaso-occluding element at a timepast any point in the lumen. Thus, the vaso-occluding elements may bedispensed with a hydrating fluid into the catheter lumen one at a time.The method can be employed with both filaments and particles.

BRIEF DESCRIPTION OF THE DRAWINGS

[0036]FIG. 1 is a perspective view of a container.

[0037]FIG. 2 is an illustration of a catheter assembly.

[0038]FIG. 3a is an illustration of an application showingvaso-occluding particles being delivered to a plurality of blood vesselsfor treatment of a tumor.

[0039]FIG. 3b is an illustration of another application showingvaso-occluding particles being delivered to an aneurysm.

[0040]FIG. 4 is an exploded view of a catheter assembly.

[0041]FIGS. 5a-5 n are partial cross sectional views of variouscontainers for holding vaso-occluding particles.

[0042]FIGS. 6a-6 k are partial cross sectional views of variouscontainers for holding vaso-occluding elements.

[0043]FIG. 7a is a partial cross sectional view of another catheterassembly having a rotatable multi-passageway container.

[0044]FIG. 7b is a cross sectional view of the container shown in FIG.7a taken along line 7B-7B.

[0045]FIG. 7c is a cross sectional view of the container shown in FIG.7a taken along line 7C-7C.

[0046]FIG. 7d is a cross sectional view of yet another catheter assemblyhaving a planar-shaped multi-passageway container.

[0047]FIGS. 8a-8 d are illustrations of various techniques for breakingor severing a filament.

[0048]FIGS. 9 and 10 illustrate a preferred embodiment of a containersystem constructed in accordance with the principles of the presentinvention. FIG. 9 shows system components in an exploded view, whileFIG. 10 shows the system in an assembled view.

[0049]FIGS. 11A and 11B illustrate alternative delivery tube-catheterhub interface configurations taken along line 11-11 of FIG. 10.

[0050]FIGS. 12A and 12B illustrate an exemplary method according to thepresent invention for capturing and loading a filament into thecontainer system of FIGS. 10 and 11.

[0051]FIGS. 13 and 14 illustrate alternative delivery tubeconfigurations which could be used with the container system of FIGS. 10and 11.

DETAILED DESCRIPTION OF THE INVENTION

[0052] Described below are containers and methods for holding anddelivering vaso-occluding materials to a target site.

[0053] FIGS. 1-2 illustrate one variation of a container. In particular,a barrel-shaped container (10) is shown holding vaso-occluding materials(12) described further below. The container (10) includes a fluid inletport (14), which can be removably connected to a fluid source such as asyringe (18). The container (10) further includes a fluid outlet port(16) which can be removably connected with a vaso-occlusive deliverydevice such as delivery catheter (20).

[0054] During operation, fluid pressure from the syringe drives thevaso-occluding materials from the container (10) into the deliverycatheter (22). Fluid pressure is further supplied to urge thevaso-occluding materials through the delivery catheter and out itsdistal end (22). In this manner, vaso-occluding materials are deliveredto a target site. Target sites include, but are not limited to, theabnormal vasculature of a tumor, aneurysms and other sites of abnormalblood flow as well as vessels, ducts and cavities that are not part ofthe blood vascular system.

Vaso-Occluding Elements and Materials

[0055] The containers described herein may hold and introducevaso-occluding elements and materials into a delivery catheter. Thevaso-occluding elements include but are not limited to vaso-occludingparticles (e.g. biocompatible polymeric microspheres) and vaso-occlusivefilaments and filamentary materials (e.g., hydrophilic polyacrylonitrileor HYPAN). The vaso-occluding elements may be made from a variety ofsubstances including hydrogel polymers and other polymers. Examples ofhydrogel polymers and polymers include: polyacrylamide (PAAM), poly(N-isopropylacrylamine) (PNIPAM), poly (vinylmethylether), poly(ethylene oxide), poly (vinylalcohol), poly (ethyl (hydroxyethyl)cellulose), poly(2-ethyl oxazoline), Polylactide (PLA), Polyglycolide(PGA), Poly(lactide-co-glycolide) PLGA, Poly(e-caprolactone),Polydiaoxanone, Polyanhydride, Trimethylene carbonate,Poly(β-hydroxybutyrate), Poly(g-ethyl glutamate),Poly(DTH-iminocarbonate), Poly(bisphenol A iminocarbonate),Poly(orthoester) (POE), Polycyanoacrylate (PCA), Polyphosphazene,Polyethylenoxide (PEO), Polyethlglycol (PEG), Polyacrylacid (PAA),Polyacrylonitrile (PAN), Polyvinylacrylate (PVA), Polyvinylpyrrolidone(PVP), a co-polymer of two or more polymers, and a blend of two or morepolymers.

[0056] The hydrogel polymer or polymers may also comprise a naturalpolymer. Examples of natural polymer include collagen, silk, fibrin,gelatin, hyaluron, cellulose, chitin, dextran, casein, albumin,ovalbumin, heparin sulfate, starch, agar, heparin, alginate,fibronectin, fibrin, keratin, pectin, elastin, and copolymers and blendsof the polymers.

[0057] Alternatively, the materials may comprise a bioactive agent andor a radio-pacifier to facilitate visualization of the vaso-occludingmaterials at a target site.

[0058] A particular element which may be used in conjunction with thecontainers described herein is a hydrogel filament. In one variation,the filament is comprised of an extruded polyacrylonitrile. One way offabricating such a filament is by the process of dissolving thepolyacrylonitrile in DMSO and extruding it into an alcohol bath,whereupon the polyacrylonitrile solution forms a filament. The filamentis then removed from the alcohol (e.g. isopropyl or like alcohol) andallowed to dry. Prior to implantation in a patient the filament may behydrated. Alternatively, the filament may be stored in a hydrated state.The filament can then be injected or delivered in a delivery tool to achosen site in the patient. The hydrated filament forms a vaso-occlusivefilamentous mass and occludes normal flow.

[0059] Dimensions for the vaso-occlusive devices may be as desired for aspecific purpose, but generally would be in a range from about 0.005inches (0.125 mm) to about 0.50 inches (12.5 mm). The diameter of theoccluding particles will typically be in the range of 40 μm to 2 mm,usually from 100 μm to 1400 μm. The filaments and other occludingfilamentary materials may have a diameter in the range of 75 μm to 5 mm,usually 100 μm to 2 mm, more usually from 100 μm to 1 mm. Also, thediameter of the vaso-occlusive materials may be selected such that theymay pass through a delivery device such as a delivery catheter. Thelengths of the vaso-occlusive filaments as delivered may be generally inthe range from about 0.5 mm to about 5 meters, usually being from 0.5 mmto 1 meter, typically being from 10 cm to 100 cm. The width or diameterof the vaso-occlusive element once it is delivered and after it hasassumed its vaso-occluding shape (i.e., the deployed filament) may be ina range from about 75 μm to about 5 cm.

[0060] A description of particular hydrogel materials may be found inU.S. Patent Application Publication Nos. 2002/0193813A1; 2003/004533A1;2003/004568A1; and 2002/0193812A1, each of which are assigned to theassignee of the present application and hereby incorporated by referencein their entirety.

Procedural Overview of Vaso-Occluding Treatments

[0061]FIGS. 3a-3 b show examples of deploying vaso-occlusive particles.Referring to FIG. 3a, a tumor (50) is shown being treated withvaso-occluding particles (60). In particular, vaso-occluding particlessuch as the hydrogel particles discussed above are shown being deliveredfrom a delivery catheter (62) to various blood vessels (64) supplyingblood to the tumor (50). The vaso-occluding particles form blockages inthe vessels (64) leading to the tumor. Accordingly, the blood to thetumor is cut off, inhibiting tumor growth.

[0062]FIG. 3b illustrates treatment of an aneurysm (70). In FIG. 3b,vaso-occluding particles (72) are delivered into the aneurysm (70). Thevaso-occluding particles form an occlusive mass in the aneurysm,minimizing its undesirable effects on the artery.

[0063] Also, instead of (or in addition to) vaso-occluding particles,occluding filaments may be supplied to form blockages in the vessels oran occlusive mass in the aneurysm.

[0064] It is to be understood, however, that the containers andoccluding materials described herein are not limited to occluding bloodvessels or aneurysms. Rather, the containers and occluding materialsdescribed herein may be used to form occlusions in any of the vessels,ducts, and cavities found in the body including but not limited tovessels found in the blood vasculature.

[0065] In both FIGS. 3a and 3 b, the distal tip of a delivery catheter(62, 74) is positioned near the target site via a catheterizationprocedure. One catheterization procedure for treatment of variousvascular defects includes inserting a sheath into an artery such as thefemoral artery. Inserting a guidewire into the sheath and advancing theguidewire to the desired site such as a tumor or aneurysm. Next, acatheter assembly including an elongate introducer catheter is insertedinto the sheath and the catheter assembly is advanced over the guidewireto the target site. Once the catheter assembly is properly positioned atthe target site, the guidewire is removed from the introducer catheter.A delivery catheter is then inserted within the introducer catheteruntil the distal end of the delivery catheter is positioned at the siteto be embolized. Vaso-occluding materials are fed into the deliverycatheter and delivered to the treatment site.

[0066] Additional examples of catheter assemblies are discussed in, forexample, U.S. Pat. Nos. 5,382,260 and 5,476,472. Also, other catheterassemblies known to those of skill in the art may be used in conjunctionwith the delivery devices and occluding materials described herein.Devices and methods for treating aneurysms and the like are alsodescribed in U.S. application Ser. No. 10/106,870 filed Mar. 25, 2002entitled “Devices And Methods For Treating Vascular Malformations” bySepetka et al. which is a continuation in part application of U.S.application Ser. No. 09/695,637, filed Oct. 24, 2000, which is acontinuation in part of U.S. application Ser. No. 09/324,359 filed Jun.2, 1999, each of which is incorporated by reference in its entirety.

[0067] Vaso-occluding materials may be delivered to a treatment sitethrough a delivery catheter. An example of a particular deliverycatheter assembly (400) for use with the present invention is shown inFIG. 4 and includes a syringe (410), a cartridge or container (420) anda delivery catheter (430). The delivery catheter assembly shown in FIG.4 shows the cartridge separated from the syringe. However, the inventionis not so limited and the cartridge may be integrally connected with thesyringe. In yet another variation, the cartridge is integral with thedelivery catheter (430). Kits may also be provided having a cartridgewith a plurality of vaso-occluding particles and or a hydrating liquidcontained therein.

[0068] To reiterate, these various containers and cartridges may beconnectable with a delivery catheter. As described, vaso-occludingmaterials held in the containers may be hydrated, washed, or mixed inthe container. The vaso-occluding materials may then be injected intothe delivery catheter by fluid pressure or some other way such as by useof a displacement wire for implantation in a target treatment site. Thecontainers may have fluid inlet and outlet ports and at least onepassageway connecting the fluid inlet port to the fluid outlet port. Theshapes, number of passageways, and other features of the containers maytake various configurations, discussed below.

Containers for Holding Vaso-Occluding Particles

[0069]FIG. 5a illustrates a container (510) having a cylindrical shapefor holding vaso-occlusive materials. The container includes a fluidinlet port (512) and fluid outlet port (514). The fluid inlet port andthe fluid outlet port are adapted to fluidly connect the container to asyringe and delivery catheter respectively. The ends of the containermay have Luer-type fittings for convenient assembly with the syringe anddelivery tool.

[0070] In this variation, the container includes a chamber or passageway(516) fluidly connecting the fluid inlet port and the fluid outlet port.A liquid (518) and vaso-occluding particles (520) are held in thechamber (516). The particles are urged towards the fluid outlet port(514) by fluid pressure and flow. The vaso-occluding particles areinjected into, for example, a delivery catheter (not shown) through thefluid outlet port.

[0071] The container may be made of various materials such as but notlimited to polymers, copolymers, glass, metals or alloys. For example,the container may be made of a transparent polymer material such asclear polycarbonate. The container may be fabricated in components orsections and bonded together using heat treatment, adhesives andultrasonic welding, for example. The container and its components maybe, for instance, injection molded, machined and micromachined. Othertechniques for forming the container and or its components may be usedas is known to those of skill in the art. The container may alsocomprise a variety of coatings or treatments such as a hydrophiliccoating.

[0072] The dimensions of the container should be sufficient such thatthe containers can fluidly connect with various conventional syringesand delivery catheters. However, the dimensions may vary such that thecontainer may be adapted to connect with other types of liquid sources(e.g., a gas line) and delivery devices.

[0073]FIG. 5b illustrates another container (530). The container (530)shown in FIG. 5b differs from that shown in FIG. 5a in that the chamberincludes a ramped portion 532. Ramp portion (532) focuses thevaso-occluding particles (534) at the outlet port. This generally servesto “meter” the particles as they are ejected from the container,preventing clumping.

[0074]FIG. 5c illustrates another container (534) also having a rampedportion (536). However, in this variation, a fluid relief lumen (538) isprovided along the ramped portion. A plurality of relief openings (539)fluidly connect the chamber to the fluid relief lumen. The reliefopenings are sized to permit only liquid (not the vaso-occludingparticles) into the fluid relief lumen.

[0075] Accordingly, liquid may be driven through the container and intothe delivery catheter regardless of the degree of particle clogging atthe container outlet. In this variation, therefore, vaso-occludingparticles in the catheter may be pushed through the catheter by fluidpressure regardless of the degree of particle clogging in the container.

[0076]FIG. 5d illustrates another container (540) having a first chamber(542) for holding a plurality of vaso-occluding materials (544) and apassageway (546). The diameter of the passageway (546) may be adjustedto provide an optimal particle throughput. In this variation thepassageway has a diameter equal to that of a particle (548). The narrowpassageway (546) is to help organize the particles as they enter adelivery catheter (not shown).

[0077]FIG. 5e illustrates yet another container (554). The containershown in FIG. 5e differs from that shown in FIG. 5d in that thecontainer (554) of FIG. 5e includes a spiral passageway (556). Like thecontainer shown in FIG. 5d, the container shown in FIG. 5e provides fororganized particle transport and ejection.

[0078]FIG. 5f illustrates yet another container. The container shown inFIG. 5f includes a mixing member (560) for displacing the vaso-occludingmaterials. Mixing the particles prevents the particles from clumping.Mixing member (560) includes a handle portion that is outside thecontainer and a working portion that is inside the chamber. The mixingmember may also include fingers (562). The fingers (562) contact andmove the vaso-occluding materials when the mixing member is moved (orrotated). The mixing member may be movable linearly and or angularly.Accordingly, the variation shown in FIG. 5f provides a container whichactively prevents clumping of vaso-occluding particles near the outlet.

[0079]FIG. 5g illustrates a container having a constant diameterpassageway (572) and a tapered distal end (570). When the container isconnected with a delivery catheter, the tapered distal end (570) extendsinto the proximal end of the catheter. This extends the constantdiameter passageway into the delivery catheter and alleviatesproblematic flow effects arising from the entrance of the deliverycatheter.

[0080]FIG. 5h illustrates another container having a one-way valve(578). The valve (578) may be a duckbill valve made of an elastomericmaterial which remains closed in its relaxed state. Upon applying fluidpressure from the fluid inlet port (580), the valve opens allowing fluidto pass. However, fluid and particles cannot pass the other direction.The valve may be positioned at the outlet end or at another location ofthe container. Also, multiple valves may be used to provide particularflow control schemes.

[0081] The vaso-occluding particles may be hydrated with a hydrationliquid and the hydration liquid may be pushed through, for example, ascreen or membrane or the like. A second liquid may be supplied to thecontainer to purge the first liquid and to drive the vaso-occludingparticles to a desired site. The second liquid may be a therapeuticliquid. Examples of therapeutic liquids include but are not limited toanalgesics, anesthetics, antibiotics, thrombotic agents,chemotherapeutic drugs, and thrombolytic agents. A particular example isdoxorubicin, which is used to treat tumors. Also, a contrast agent forvisualization can be used. Accordingly, the target site can besimultaneously treated with embolizing particles and a therapeuticliquid.

[0082]FIG. 5i illustrates a variation using a movable screen (582). Thescreen has openings, which allow liquid, but not particles, to pass. Thescreen (582) may be pie shaped as shown in FIG. 5l and it may have atleast one open region (583) (or open “slice”). Also, the open region mayinclude apertures so long as at least one of the apertures is largerthan the vaso-occluding particles. When this particle-passing region(583) is aligned with an opening on a screen support such as support(585), vaso-occluding particles may pass therethrough. When the regionsare not aligned, only fluid (and not the particles) may pass.

[0083]FIG. 5j illustrates a container having a fixed screen (584) and acap (588) covering the outlet (586). The screen has openings that permitfluid, but not particles, to pass. The container shown in FIGS. 5i-5 jmay be used to hydrate vaso-occluding particles and provide a way toreplace the hydrating fluid with a second, perhaps therapeutic fluid.

[0084]FIG. 5k illustrates another container (590). In this example, thecontainer (590) includes a spiral passageway (592) leading to a rampedchamber (594). The ramped chamber further leads to a straight passageway(596).

[0085] The spiral passageway (592) includes at least one particleaperture (598) through which vaso-occluding particles moving along thepassageway may pass. Thus, some particles fall through the apertures(598) and other particles continue down the spiral passageway (592). Theparticles that fall through the apertures bypass one or more turns inthe spiral passageway and directly enter the ramped section (594). Theramped chamber shown in this variation is tapered and focuses theparticles into a straight passageway (596) which accepts only oneparticle at a time. Accordingly, the container (590) focusesvaso-occluding particles into an attached delivery catheter (not shown).

[0086]FIG. 5m shows a container (1500) having a helical passageway(1502) extending from a fluid inlet (1504) to a fluid outlet (1506). Thehelical passageway of FIG. 5m, however, does not include apertures alongits path so that particles (and/or filaments) stay in line along thehelical path before reaching the fluid outlet. In still anothervariation, as shown in FIG. 5n, a container (1510) has a helical path(1512) extending from an inlet (1514) to a ramped section (1516) whichfocuses or funnels the occluding materials to a fluid outlet (1518).Accordingly, containers described herein may have helical passagewayswhich do include apertures along their paths and helical passagewayswhich do not include apertures along their paths. The helicalpassageways may extend to fluid outlets or the passageways may lead toanother focusing chamber such as a ramped section, which focuses theoccluding materials to a fluid outlet.

Containers for Holding Vaso-Occluding Filaments

[0087] The containers described herein may also hold and delivervaso-occluding filaments, such as those described in the co-pendingapplications incorporated herein by reference above, the fulldisclosures of which are incorporated herein by reference.

[0088]FIG. 6a illustrates a particular container (600) suitable fordelivering a filament (602). Similar to the above described containers,the container (600) shown in FIG. 6a includes an inlet (604) forreceiving liquids, a passageway or chamber (606) for holding thefilament and liquids (607), and an outlet (608) for ejecting thefilament and or liquid. The inlet end and outlet end can be designed tofluidly connect with a fluid source (e.g., a syringe) and a deliverycatheter respectively. In operation, the filament is hydrated andejected from the outlet (608) into, for example, a delivery catheter.The chamber shown in FIG. 6a may be cylindrical and substantially largerin diameter than the filament (602). However, the invention is not solimited and other shapes of chambers are contemplated.

[0089]FIG. 6b illustrates another container (610) having a spiralpassageway (612). The spiral passageway (612) is very space efficientand holds very long filaments in short containers. A displacement memberor wire may be provided to push the filament through the passageway. Thedisplacement wire may be a flexible metal or alloy. The displacementwire may be made of, for example, NITINOL. Such a displacement membermay include markings along its length. The marks may be equally spacedto provide an idea or measure of the length of filament ejected from thedistal end of the catheter. Alternatively, syringes connected at distalend (611) of the container (610) may be used to draw in and ejectindividual or multiple filaments.

[0090]FIG. 6c shows yet another container (620) having a set of gangedpassageways (622) for holding and delivering multiple filaments (624) inparallel. The container (620) shown in FIG. 6c also includes a rampedportion (626) to focus the filaments towards the delivery end. FIG. 6dshows a cross sectional view of the container along 6 d-6 d. Thiscontainer provides for multiplexed filament delivery.

[0091]FIGS. 6e-6 f illustrate another container (630) for holdingfilaments (632). The container (630) shown in FIGS. 6e and 6 f is shapedlike a disk. The container (630) includes a passageway (634) for holdingand delivering a filament (632) from an inlet (636) to an outlet port(638). The passageway may be a spiral, serpentine, or other curved shapeto connect the inlet (636) to the outlet (638). Also, it is to beunderstood that the shape of the container may vary greatly and include,for example, cylindrical, disk, rectangular, oval, turnip, and othershapes.

[0092]FIGS. 6g and 6 h illustrate another container (640) similar infunction to those shown in FIGS. 6e-6 f. These figures depict acenterline of inlet (642) and the centerline of outlet (644) separatedby a distance (D).

[0093]FIG. 6i illustrates yet another container (650) including amembrane (652) between a base (654) and a cover (656). The base,membrane and cover are detachably connected such that pre-selectedmembranes may be added or removed for various applications. Also, thecomponents should be fluidly sealed to prevent leaks.

[0094] One application for container (650) is filament hydration. Ahydrating liquid is supplied to the passageway (662) via inlet (658),hydrating the contents therein. The liquid may then be driven throughmembrane (652) and ejected from outlet (660). The membrane includesopenings that prevent the filament from passing therethrough yet allowthe hydrating liquid to pass therethrough. A variety of membranes andfilters may be used to selectively allow certain substances to pass.Once the filament is hydrated, the membrane is removed and the containeris connected with a delivery tool to deliver the filament to a targetsite.

[0095]FIGS. 6j-6 k illustrate yet another container (670) having aconical end section (674). The conical end section (674) has a fluidoutlet port allowing liquids and vaso-occluding materials to flowtherethrough. The conical end section (674) is adapted to extend into(and mate) with the proximal end of a delivery catheter.

[0096] The conical distal end section (674) also includes rinse ports(676) as shown of FIG. 6k. The rinse ports (676) are sized to preventvaso-occluding materials such as filaments and particles from flowingtherethrough but allow liquid to pass therethrough.

[0097] An application for container (670) is filament hydration anddelivery. A hydrating liquid is injected into the container. Thehydrating liquid hydrates the filament, and exits through the rinseports (676). The vaso-occluding materials, however, are prevented frompassing through the rinse ports due to their size and are prevented frompassing through the outlet port (680) due to the cap (678). Once thefilaments are hydrated, a second liquid can be supplied to the containerpurging the hydrating liquid from the system. The cap may then beremoved and the container may be connected with a catheter assembly.

[0098] The distal end section (674) may be designed such that the rinseports (676) are covered by the delivery catheter entrance (not shown)when the catheter is connected with the container. In particular, theconical section (674) extends into the catheter hub such that the rinseports (676) are covered. Accordingly, vaso-occluding materials and orliquids are forced to pass through the fluid outlet port (680) and intothe delivery catheter.

Rotatable Multi-Passageway Container

[0099]FIGS. 7a-7 c show several views of a delivery catheter assemblyhaving a rotatable multi-passageway container (710). In this variation,a catheter assembly (700) includes a container (710) having a pluralityof passageways (712) for holding filaments (714), a syringe (720) forsupplying fluid to the container to hydrate and drive the filaments, anda delivery catheter (730) for delivering the filaments to a target site.

[0100] The container shown in FIG. 7a includes a revolving barrel (740).The barrel revolves about a central axis. The revolving barrel includesa plurality of passageways (714). The passageways are circumferentiallypositioned along a circle. See, for example, FIG. 7b. Each passageway(714) is configured to hold vaso-occluding filament. The passageways maytake various shapes and be, for example, straight or curved.

[0101] The revolving barrel also has a fluid inlet port that is fluidlyconnected with a syringe. The barrel further has a distal end and thepassageways extend to the distal end, defining an equal number offilament exit ports. There are four passageways shown in this figure butthe invention is not so limited and the barrel may have more or lesspassageways.

[0102] The container also includes a body (750), which fluidly connectsone of the passageways (714) with the proximal end of the deliverycatheter (730). The body includes one channel (752) which can align (orregister) with a selected passageway of the plurality of passageways(714). See also FIG. 7c. Once a passageway is aligned with the channel acomplete fluid pathway is formed from the syringe to the deliverycatheter. Accordingly, a selected filament may be ejected from thecontainer into the delivery catheter.

[0103] It is to be understood that while the above described variationshows the barrel and syringe being rotatable, the invention is not solimited. Other members may be rotated to achieve a complete fluidpathway for filament delivery. Also, the container may be “closed” byadjusting the barrel such that no passageways are aligned with thechannel, fluidly sealing each passageway.

[0104]FIG. 7d shows another catheter assembly (760) having a movablemulti-chamber container (770). This variation is different than theabove barrel shaped variation in that it is card-shaped. Also, thecontainer moves in a plane such as the XY plane. The passageways fromthe movable device are aligned with a channel of the body component(780) to create a fluid path connecting the syringe to the deliverycatheter. Accordingly, filaments may be pushed through the container andto the target site.

Filament Length Control

[0105] When delivering vaso-occluding filaments to a target site, it issometimes desirable to break or sever the filament. For example, inselecting a specific size filament for filling an aneurysm it isdesirable to break the filament at a certain location along the lengthof the filament. Various techniques for breaking the filaments aredescribed herein.

[0106] One technique for severing a filament is shown in FIGS. 8a and 8b. These figures depict inflating a balloon member (810) to pinch afilament (812) between the balloon and the inner wall (816) of adelivery catheter. As the balloon member expands it continues to pinchthe filament until the filament severs.

[0107] Another “pinching” technique is shown in FIG. 8c. In FIG. 8c, anenlarged member (820) is provided. When the enlarged member (820) ismoved proximally, it pinches the filament (822) against the deliverycatheter wall, breaking the filament. The enlarged member may have aball shape. The enlarged member may also be, for example, a knot.

[0108] Another technique for breaking a length of filament is shown inFIG. 8d. In particular, a noose (832) surrounds the filament (834) at aselected location. The noose (832) is tightened by pulling the member(830) thereby breaking the filament. An exemplary snare device is shownin U.S. Pat. No. 6,312,421 to Boock.

[0109] Still other techniques for breaking the filament includeproviding the filament with a detachable joint. The detachable joint maybe activatable or dissolvable upon receiving various stimuli such as,for example, blood, pH, electricity, heat, and other stimuli. Thedetachable region may be scored or otherwise designed to incorporate alocalized weak region in the filament. The filament may be stretchedacross a localized region and the filament will break at the weakenedpoint.

[0110] It is to be understood that the filament may be broken or severedat a point distal to the catheter end, within the catheter, and perhapswithin the container.

[0111] The filament may also contain discrete sections along its lengthto provide information to the doctor or physician. This information orfeedback may be provided by incorporating bulges, knots, radio-opaquemarkers, or other types of discrete sections (or features) along thelength of the filament. The discrete sections may be separated bysegments of known length. A sensor may be positioned on the distal endof the delivery catheter to monitor the number of segments exiting thedelivery catheter. Given the length of each segment, and the number ofsegments ejected, the total length of filament dispensed from thecatheter may be determined. Once a desirable length of filament has beenejected, the filament is cut. The bulges, knots, etc. may also be usedto trigger a mechanism that severs the filament.

Applications

[0112] As indicated above, containers may hold and introducevaso-occluding materials to a delivery catheter. The containers may beshipped or delivered to a doctor in a kit form that is ready to be used.Such kits may be designed to include both or either hydrated orunhydrated particles and filaments. Shipping the filaments in aready-to-use kit minimizes compression of filaments. For example,shipping the filament in a ready-to-use hydrated state minimizes thechance that a filament will break during shipping. Some types offilaments are brittle in their unhydrated state.

[0113] Also, the vaso-occluding materials may be packed in particularconfigurations to optimize packing (e.g., increase packing density).Particles and filaments may be formed in certain shapes (having certaincross sections) such as cubic, hexagonal and triangular so that theparticles or filaments interlock and minimize dead space. Spherical andcylindrical shapes may have more dead space when the particles arepacked together.

[0114] These devices may be used in a wide variety of ways. For example,the vaso-occluding materials may be designed for implantation into thevasculature of a patient. The implantation site may be any site ofabnormal blood flow in the patient such as the brain. The abnormal bloodflow may be caused by an aneurysm, a ruptured blood vessel, an AVM, afistula, or a benign or malignant tumor (e.g., cancer or fibroid or thelike). Otherwise untreatable tumors are particularly contemplated fortreatment by implantation of the vaso-occlusive devices of theinvention, as are uterine fibroids and the like. Additionally, thevaso-occlusive devices may be designed for implantation into vessels,ducts and cavities found in the body which are not part of the bloodvascular system.

[0115] The containers and kits also provide for conveniently hydratingand dispensing particles in a single step. That is, in a single stepliquids can be supplied to the container to hydrate the vaso-occludingmaterials and push them into the delivery catheter. Consequently, thereis less likelihood of contamination.

[0116] Additionally, various therapeutic liquids may be used with thepresent invention. The therapeutic liquids are added to the container,purging the first liquid if necessary. Also, the present inventionprovides for breaking the filaments at certain locations along theirlengths. The length of filament ejected may thusly be controlled. Also,graduated lengths of containers may be provided. Each container caninclude a length of filament corresponding to the size of container.

[0117] Referring to FIGS. 9 and 10, an exemplary system (900) forholding and delivering vaso-occluding elements to target body locations,typically in the vasculature, will be described. While the systemcomprises up to four components, a container (902) comprising a deliverytube (904) is the principal novel component of the system. The system(900) may also include a syringe (906) or other conventional device fordelivering a hydrating liquid or other fluid under pressure, andimplanted catheter (908) comprising a catheter body (910) and a proximalcatheter hub (912) (shown in section), and a hemostasis valve (914). Thedelivery tube (904) has the dimensions generally set forth above, and istypically composed of a polymer, such as polyethylene, although incertain circumstances it could be formed from a metal, glass, or othermaterial. Delivery tube (904) has an inlet end (920) and an outlet end(922), with a Luer or other inlet coupling (924) attached to the inletend. The outlet end (922) is typically configured as a straight sectionof the tube (904), although it would be possible to provide connectioninterfaces or otherwise configure the straight end, as described belowin connection with FIGS. 11A and 11B.

[0118] Because of its length, it is usually desirable to configure orstructure the delivery tube (904) so that it occupies a considerablylesser length in the container (902). As illustrated in FIG. 9, thedelivery tube (904) may be helically coiled over a portion of itslength, thus shortening the overall effective length of the container.For example, delivery tubes having lengths in the range from 5 cm to 10meters, usually from 5 cm to 5 meters, may have coils with a diameter inthe range from 5 mm to 20 mm, with from 2 turns to 1000 turns, usuallyfrom 5 to 100 turns. Other configurations for shortening the effectivelength of the delivery tube (904) include planar coils (FIG. 13), planarserpentine configurations (FIG. 14), and the like. As shown in FIG. 9,the coiled section (930) of the delivery tube (904) is mounted over abarrel (932) and/or within an outer tube (934).

[0119] The hydratable elements to be delivered by system (900) will becontained in a lumen of delivery tube (904). The hydratable elements maybe stored in a hydrated, partially hydrated, or non-hydrated form, butwill in at least most cases be fully hydrated before delivery. Thesyringe (906) may be utilized for delivering the hydrated vaso-occludingparticles from the delivery tube (904) of container (902). Inparticular, the syringe may be attached to the Luer fitting (924), asillustrated in FIG. 10. The syringe will be filled with a hydratingmedium or other suitable liquid for delivery through the delivery tube(904), thus permitting delivery of the hydrated elements by pressurizedintroduction of the hydrating medium or other liquid.

[0120] Referring now to FIGS. 11A and 11B, the outlet end (922) ofdelivery tube (904) is received in a passageway (940) of the catheterhub (912). Preferably, a pressure-type seal (i.e., a seal which preventsleakage under the expected infusion pressures) will be formed betweenthe outlet end (922) and the interior wall of the hub passage (940). Forexample, a spherical seal (942) may be formed at the distal tip of thedelivery tube (904), where the spherical seal engages and seals againsta tapered region of the passageway in the catheter hub. Alternatively,the distal end of the delivery tube (904) may itself be tapered so thatit seats in and seals against the passageway (940), as shown in FIG.11B. Optionally, as shown in FIG. 11C, the outlet end (922) may be heldin a spring (923) which allows the spherical seal (942) to compressiblyengage the interior (940) of the hub (912). The hub (912) will bedirectly connected to a Luer or other fitting (925) in the container(902). It would also be possible to substitute a screw mechanism for thespring, although that option is not illustrated. In either case, anyextension or compression of the tube (904) can be accommodated bycompression or extension of the helical portion of the tube, i.e., thehelix will simply act like a spring. In some cases, by properlycontrolling the elasticity of the tube material, the helical section ofthe delivery tube (904) could provide the necessary spring force and noseparate spring (923) would be necessary.

[0121] While it is generally preferred to form a seal within thecatheter hub, a separate hemostatic valve (914) may be provided forsealing against the exterior of the delivery tube (904) at a locationimmediately proximal to the hub (940), as illustrated in FIG. 10. Ahemostatic seal (914) includes Luer fittings at each end so that it maybe positioned between the proximal end of hub (912) and distal end ofcontainer (902), as illustrated in FIG. 10. By sealing over the exteriorof the straight portion of delivery tube (904), a relatively small,enclosed volume is created between the hemostasis valve and the proximalend of catheter body (910). While this volume will receive some flow andpressure from the hydrating medium being introduced through the lumen ofthe delivery tube (904), the pressure will quickly equalize and thepassage of vaso-occluding element(s) and hydrating medium into the lumenof the catheter body (910) will quickly be accomplished.

[0122] The container system (900) may be sterilely packaged anddistributed either with or without pre-loaded vaso-occluding element(s).When pre-loaded, the vaso-occluding elements may be hydrated, partiallyhydrated, or non-hydrated, and at least the container (902) holding thevaso-occluding element(s) will be sterilely packaged. Optionally, othersystem components may be combined in the same or a separate sterilepackage.

[0123] Alternatively, the container (902) and/or other system componentsmay be sterilely packaged and distributed separately from thevaso-occluding element(s). In that case, it will be necessary to loadthe vaso-occluding element(s) into the delivery tube (904) prior to use.As illustrated in FIGS. 12A and 12B, a filament F may be loaded into thedelivery tube by first hydrating the filament in a suitable hydratingmedium H in a bowl, dish, or the like. After the filament has beenhydrated, the outlet end (922) of the delivery tube (904) may beimmersed in the hydrating medium H and located next to one end of afilament F. By then pulling on the plunger in syringe (906), hydratingmedium and the filament is drawn into the delivery tube, as shown inFIG. 12B. Usually, the delivery tube (904) will be primed with hydratingmedium H prior to drawing in the filament F.

[0124] While the container (902) having a helical delivery tube (904) isillustrated in FIGS. 9 and 10, other delivery tube configurations arealso possible. As shown in FIG. 13, a delivery tube (980) may beconfigured as a spiral on one side of a card (982). On the center of thecard, the tube may be drawn through to the other side and brought out sothat an inlet (984) is available for connection to a syringe, typicallywith a Luer (986). The delivery or outlet end (988) of tube (980) may beprovided with any of the configurations discussed with priorembodiments.

[0125] As a further alternative, a delivery tube (990) may be formed ina serpentine pattern on a support card (992). An outlet or delivery end(994) can extend from one side of the card, while an inlet end (996)having a Luer fitting (998) extends from the other side of the card. Ingeneral, both delivery tubes (990) and (980) can be used in place ofcontainer (902) and delivery tube (904) in the container system of FIGS.10 and 11.

[0126] Other features that may be incorporated into the apparatus of thepresent invention include mixing mechanisms in the delivery chamber ordelivery tube, e.g., fluid flow or a mixing member coupled to thesyringe plunger which is advanced with depression of the plunger to mixthe elements, particularly particles, to assist in advancement from thedelivery chamber to the catheter. It may also be useful to graduate orotherwise mark the delivery tube to indicate filament length,particularly where the marking instructs the user where to cut the tubeto ensure compatibility with the catheter hub.

[0127] All publications, patent applications, patents, and otherreferences mentioned herein are incorporated by reference in theirentirety. To the extent there is a conflict in a meaning of a term, orotherwise, the present application will control.

[0128] Although the foregoing invention has been described in somedetail by way of illustration and example for purposes of clarity ofunderstanding, it will be readily apparent to those of ordinary skill inthe art in light of the teachings of this invention that certain changesand modifications may be made thereto without departing from the spiritor scope of the appended claims.

What is claimed is:
 1. A kit for holding vaso-occluding elementscomprising: a plurality of hydratable vaso-occluding elements; and acontainer adapted to hold the hydratable vaso-occluding elements, saidcontainer having an inlet port and an outlet port, wherein at least oneof the fluid inlet and outlet ports is adapted for fluid connection witha fluid source.
 2. The kit of claim 1 wherein the container comprises achamber to hold said elements, said chamber having a varying crosssectional area.
 3. The kit of claim 2 wherein said varying crosssectional area decreases in a direction from the inlet port to theoutlet port.
 4. The kit of claim 2 wherein said chamber has a firstsection and a second section and wherein said first section has a firstcross sectional area and said second section has a second crosssectional area different than said first cross sectional area.
 5. Thekit of claim 4 wherein said second cross sectional area decreases in adirection towards the fluid output port.
 6. The kit of claim 5 whereinsaid first cross sectional area is constant.
 7. The kit of claim 1comprising at least one passageway, said passageway being adapted toallow a controlled number of elements to pass therethrough at a time. 8.The kit of claim 7 wherein said passageway is straight.
 9. The kit ofclaim 7 wherein said passageway is curved.
 10. The kit of claim 9wherein said passageway has one of a spiral or helical shape.
 11. Thekit of claim 1 wherein said elements are particles and the containerfurther comprises a mixing member, said mixing member being elongate andhaving a first section outside of said container and a second sectionwithin said container for stirring said particles.
 12. The kit of claim11 wherein said second section of said mixing member includes fingersand wherein said mixing member is rotatable.
 13. The kit of claim 1wherein said container comprises a conical distal section, said conicaldistal section decreasing in diameter and terminating at said fluidoutput port.
 14. The kit of claim 13 wherein said conical distal sectionis adapted to fit within a proximal end of a delivery catheter.
 15. Thekit of claim 1 further comprising a one-way valve positioned at at leastone of said fluid inlet port and fluid output port wherein when saidone-way valve is disposed at said fluid inlet port the valve permitsflow only into said container and when said valve is positioned at saidfluid output port said valve permits flow only out of said container.16. The kit of claim 1 wherein said elements are particles and saidcontainer further comprises first chamber in fluid communication withsaid inlet port and a second chamber in fluid communication with saidoutlet port, said first chamber and said second chamber separated by asupport member having at least one opening and said at least one openingbeing larger than said particles such that when said at least oneopening is not covered, fluid and said particles may pass through, saidcontainer further comprising a movable screen positioned across saidsupport, said screen having at least one particle-blocking section andat least one particle-passing section, said particle-blocking sectionhaving a plurality of apertures smaller than said particles and saidparticle-passing section having at least one aperture larger than saidparticles, said screen being movable such that when saidparticle-passing section of said movable screen is aligned with saidopening of said support said particles may enter said second chamber andwhen said particle-passing section of said movable screen member is notaligned with said at least one opening of said support said particlesmay not enter said second chamber.
 17. The kit of claim 1 wherein saidcontainer further comprises a screen member disposed across said outlet,said screen member having a plurality of apertures and each of saidapertures being smaller than said elements such that said elements maynot pass through said outlet.
 18. The kit of claim 1 wherein saidelements comprise polyacrylonitrile.
 19. The kit of claim 18 whereinsaid elements comprise spherical particles.
 20. The kit of claim 19wherein said particles have an outer diameter in the range of 40 μm to 2mm.
 21. The kit of claim 1 further comprising a liquid in said containerand wherein said elements are hydrated.
 22. The kit of claim 1 furthercomprising at least one cap covering one of said fluid inlet port andfluid outlet port.
 23. The kit of claim 1 further comprising a Luerfitting for connecting said fluid source to said fluid inlet port. 24.The kit of claim 1 further comprising a Luer fitting for connecting saidoutlet port with a delivery catheter.
 25. The kit of claim 1 whereinsaid container further comprises at least one fluid relief port and atleast one fluid relief passageway connected to said fluid relief portwherein said at least one fluid relief port has a diameter less than thediameter of said elements and wherein liquid driven through saidcontainer flows through said chamber and said fluid relief passagewaywhile said elements flow only through said chamber to said fluid outletport.
 26. A kit comprising: at least one hydratable vaso-occludingfilament; and a container hold adapted to hold the filament and havingan inlet and an outlet wherein at least one of the inlet and outlet isadapted for connection to a fluid source.
 27. The kit of claim 26wherein the inlet is adapted to receive a fluid source and the outlet isadapted for connection to a delivery catheter.
 28. The kit of claim 27wherein said fluid source is a syringe.
 29. The kit of claim 26 whereinsaid filament comprises polyacrylonitrile.
 30. The kit of claim 26wherein said container comprises a passageway having a cross-sectionalgeometry which allows only one filament of occluding material to passthrough at a time.
 31. The kit of claim 30 wherein said filament has adiameter in the range of 100 μm to 5 mm.
 32. The kit of claim 30 whereinsaid passageway is at least partly straight.
 33. The kit of claim 30wherein said passageway is at least partly curved.
 34. The kit of claim33 wherein said passageway is spiral or helical over at least a portionof its length.
 35. The kit of claim 26 wherein said container has ashape selected from the group consisting of disk-, card-, cylindrical-,and turnip-shape.
 36. The kit of claim 26 wherein said container furthercomprises a membrane, said membrane having openings sized to preventsaid filament material from passing therethrough but allowing liquid topass therethrough.
 37. The kit of claim 26 wherein the containercomprises a rotatable barrel having multiple passageways for holdingfilaments, and a body having a single ejection channel wherein when oneof the multiple passageways is aligned with said single channel a fluidpathway is formed connecting the fluid source to the outlet port of thecontainer.
 38. The kit of claim 26 further comprising a displacementmember for pushing the filament material out the container.
 39. A methodfor introducing vaso-occluding elements into a delivery cathetercomprising: hydrating the elements in a container, said container havinganother end adapted for fluid connection with a delivery catheter; andpushing at least a portion of the material from the container throughthe catheter and to a target site.
 40. The method of claim 39 whereinsaid pushing comprises attaching a fluid source to an inlet end of thecontainer and applying fluid pressure from the fluid source.
 41. Themethod of claim 39 wherein said elements comprise at least one filament.42. The method of claim 41 wherein said pushing is performed with anelongated displacement member.
 43. The method of claim 41 furthercomprising the step of severing the filament at a selected locationalong the length of the filament.
 44. The method of claim 43 whereinsaid severing is performed by pinching the filament at said locationbetween two surfaces.
 45. The method of claim 44 wherein said pinchingis performed using an expandable balloon.
 46. The method of claim 43wherein said breaking is performed using a noose.
 47. The method ofclaim 41 wherein said filament includes discrete sections having anenlarged diameter.
 48. The method of claim 47 further comprisingdetecting the sections of enlarged diameter and breaking the filament inresponse to the detecting.
 49. The method of claim 43 wherein thebreaking is distal to the distal end of the delivery catheter.
 50. Themethod of claim 43 wherein the breaking is performed in the container.51. The method of claim 39 further comprising purging the container witha therapeutic liquid and using said therapeutic liquid for pushing. 52.A container for holding hydratable vaso-occluding elements, saidcontainer comprising: a delivery tube having an inlet end, a deliveryend, a lumen extending from the inlet end to the delivery end, a lengthfrom inlet end to delivery end of at least 5 cm and a maximum lumenwidth along its length in the range from 0.4 mm to 5 mm; and an inletcoupling disposed on the inlet end of the delivery tube, said inletcoupling being adapted to fluidly couple to a fluid source; wherein thedelivery tube is configured to reduce the length of the container.
 53. Acontainer as in claim 52, wherein the inlet coupling is a Luer connectoradapted to connect to a syringe.
 54. A container as in claim 52, whereinthe delivery tube is configured as a helix over at least a portion ofits length.
 55. A container as in claim 54, wherein the helix is woundover a cylindrical barrel.
 56. A container as in claim 54, wherein thehelix is wound inside of a cylindrical barrel.
 57. A container as inclaim 52, wherein the delivery tube is configured as a planar spiralover at least a portion of its length.
 58. A container as in claim 57,wherein the planar spiral is formed over a planar card.
 59. A containeras in claim 52, wherein the delivery tube is configured in a serpentinepattern over at least a portion of its length.
 60. A container as inclaim 52, further comprising a plurality of hydratable vaso-occludingparticles contained in the lumen of the delivery tube.
 61. A containeras in claim 60, wherein the particles have an average diameter of 75 μmto 1.5 mm.
 62. A container as in claim 60, wherein the particles are nothydrated.
 63. A container as in claim 60, wherein the particles arehydrated in a hydrating medium in the lumen.
 64. A container as in claim52, further comprising at least one hydratable vaso-occluding filamentcontained in the lumen of the delivery tube.
 65. A container as in claim64, wherein the filament has a length in the range from 1 cm to 2000 cmand a width in the range from 75 μm to 5 mm.
 66. A container as in claim65, wherein the filament is not hydrated.
 67. A container as in claim65, wherein the filament is hydrated in a hydrating fluid in the lumen.68. A container as in claim 52, wherein the delivery end of the deliverytube is straight over a length of at least 1 cm and adapted to bereceived in a hub of a delivery catheter.
 69. A container as in claim68, wherein the straight delivery end of the delivery tube is tapered toform a seal with a tapered passage in the hub of the delivery catheter.70. A container as in claim 68, wherein a spherical seal is formed overthe straight delivery end of the delivery tube to form a seal with atapered passage in the hub of the delivery catheter.
 71. A method forintroducing vaso-occluding elements into an implanted catheter, saidmethod comprising: providing said elements in a hydration liquid in adelivery tube having a lumen with a length of at least 2 cm and amaximum width along its length in the range from 0.4 mm to 5 mm; matinga delivery end of the tube with a hub of the implanted catheter; andtransferring said element(s) in the hydration liquid from the lumen andthrough the delivery end of the delivery tube into a lumen of theimplanted catheter.
 72. A method as in claim 71, wherein the deliverytube is configured as a helix over at least a portion of its length. 73.A method as in claim 72, wherein the helix is wound over a cylindricalbarrel.
 74. A method as in claim 72, wherein the helix is wound insideof a cylindrical barrel.
 75. A method as in claim 71, wherein thedelivery tube is configured as a planar spiral over at least a portionof its length.
 76. A method as in claim 75, wherein the planar spiral isformed over a planar card.
 77. A method as in claim 72, wherein thedelivery tube is configured in a serpentine pattern over at least aportion of its length.
 78. A method as in claim 71, wherein providingcomprises drawing said elements from a pool of hydrated elements intothe lumen of the delivery tube.
 79. A method as in claim 78, wherein theelements comprise a filament and drawing comprises applying a vacuum onan inlet end of the delivery tube to capture an end of the filament anddraw the length of the filament into the lumen.
 80. A method as in claim79, further comprising priming the delivery tube lumen with thehydration liquid from a syringe and then using the syringe to apply thevacuum.
 81. A method as in claim 79, wherein the filament has a lengthin the range from 1 cm to 2000 cm and a width along their length in therange from 75 μm to 5 mm.
 82. A method as in claim 71, wherein thedelivery tube is provided as a sterile package with the elements in thelumen.
 83. A method as in claim 82, wherein the elements are nothydrated in the sterile package, and providing comprises drawing thehydration liquid into the delivery tube.
 84. A method as in claim 83,wherein the elements are present in the hydration liquid in the sterilepackage.
 85. A method as in claim 71, wherein mating comprises forming aseal between the delivery end of the delivery tube and a passage of thecatheter hub.
 86. A method as in claim 85, wherein mating comprisesengaging a tapered region of the delivery end in a tapered passage ofthe catheter hub to form a seal between the delivery tube lumen and thecatheter lumen.
 87. A method as in claim 85, wherein mating comprisesengaging a plug element on the delivery end in a tapered passage of thecatheter hub.
 88. A method as in claim 85, wherein mating comprisesforming a hemostatic seal over the exterior of the delivery end of thedelivery tube and extending to the catheter hub.
 89. A method as inclaim 71, wherein transferring comprises applying pressure at an inletend of the delivery tube lumen.
 90. A method as in claim 71, whereintransferring comprises passing a push rod through an inlet end of thedelivery tube lumen and pushing the elements with the rod.
 91. A systemfor delivering vaso-occluding elements, said system comprising: at leastone hydratable vaso-occluding element having a width when hydrated; anda delivery tube having an inlet end, a delivery end, and a lumenextending from the inlet end to the delivery end; wherein the lumen ofthe delivery tube is adapted to hold said hydratable vaso-occludingelement and has a width along its length which is at least as large asthe width of the vaso-occluding element and less than twice the width ofthe vaso-occluding element.
 92. A system as in claim 91, wherein thehydratable vaso-occluding element comprises at least one filament.
 93. Asystem as in claim 91, wherein the hydratable vaso-occluding elementcomprises a plurality of particles.
 94. A method for deliveringhydratable vaso-occluding elements to a target body location, saidmethod comprising singly dispensing one or more vaso-occluding elementsthrough a delivery tube to a catheter lumen, wherein the lumen of thedelivery tube is adapted to pass only a single vaso-occluding element ata time.
 95. A method as in claim 94, wherein the vaso-occluding elementsare dispensed with a hydrating fluid into the catheter lumen.
 96. Amethod as in claim 95, wherein the hydratable vaso-occluding elementsare filaments.
 97. A method as in claim 95, wherein the hydratablevaso-occluding elements are particles.